Therapeutic Products Act (TPA)
Overview
The Therapeutic Products Act (Heilmittelgesetz, HMG / TPA, SR 812.21) is the primary Swiss legislation governing all therapeutic products — including medicinal products, blood products, and medical devices. It provides the statutory authority for the MedDO and IVDO and establishes Swissmedic as the national regulatory authority.
Key TPA Provisions Relevant to Medical Devices
| TPA Article | Content |
|---|---|
| Art. 4 | Definitions — what constitutes a therapeutic product |
| Art. 45–48 | Market access requirements for medical devices (framework) |
| Art. 58–67 | Post-market obligations — vigilance, reporting, FSCA |
| Art. 9 para. 2 | Hospital exemption for in-house manufactured devices |
| Art. 9 para. 4 | Compassionate use framework |
| Art. 36 | Named-patient import authorisation |
| Art. 82–91 | TPA Chapter 4 — Advertising |
| Art. 54–60 | Authorised representative obligations |
| Art. 86–95 | Swissmedic powers — market surveillance and enforcement |
| Art. 86ff | Criminal penalties for TPA violations |
2020 TPA Revision
The TPA was substantially revised in 2020 to provide the statutory basis for the new MedDO and IVDO, aligning Swiss medical device regulation with EU MDR/IVDR requirements. Key changes included: new definitions; updated market access framework; enhanced vigilance and post-market provisions; strengthened Swissmedic enforcement powers.
Official Sources
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